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Anteris Technologies Global Corp. — Capital/Financing Update 2008
Oct 8, 2008
33869_rns_2008-10-08_e790217a-84e8-4a0f-94bc-8728b9949074.pdf
Capital/Financing Update
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COMPANY ANNOUNCEMENT
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(ASX:BOD)
9 October 2008
PHASE II CLINICAL TRIAL UPDATE
bioMD Limited (ASX: BOD) hereby confirms the tenth patient implant of its CardioCel bioimplant.
The Company’s Phase II human clinical trial is being conducted in South Africa. CardioCel has been aproved for this Phase II trial by the Ethics Committee of the University of the Free State, Bloemfontein, South Africa. The trial is being conducted in South Africa, where there is a high incidence of congenital heart disease that causes heart deformitiies.
About the Study
The primary objectives of this trial are to evaluate the safety, efficacy and clinical performance of the CardioCel patch in cardiovascular surgical repair procedures. Secondary endpoints are the evaluation of its design features, such as handling characteristics, shape and sizing requirements, as well as implant procedures.
The CardioCel patches will be implanted into 50 patients requireing bioprosthetic tissue substitution to support repair of atrial and ventricular septal defects, aortic root enlargements and outflow tract reconstructions.
CardioCel patches are manufactured from bovine pericardium and treated with the ADAPT® Tissue Engineering Process (TEP).
Each patient will have a post-operative follow up period of 12 months. Follow-up procedures include echocardiographic examinations at 6 and 12 months to evaluate haemo compatibility, calcification status and the general efficacy and stability of the implant patch. Selected patients will also undergo magnetic resonance imaging (MRI) as part of their follow-up assessment.
About ADAPT TEP
ADAPT TEP is the only platform technology that achieves all the optimal long term objectives for both soft tissue and cardiovascular implants.
Features / Benefits:
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Site Specific controlled tissue remodeling (allows stem cell transdifferentiation);
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Conforms the collagen triple helix;
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Crosslinked with an ultra-low monomeric polymer;
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Removes all RNA and DNA including the α Gal Epitope;
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Removes all residual and unbound polymer molecules;
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Removes all calcium binding sites;
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Produces a stable soft tissue extracellular matrix.
ADAPT TEP is a proven multi-factorial approach in tissue engineering technology. Extensive in-vivo studies (refer website) have shown that enhanced crosslinking mitigates inflammation and tissue erosion.
ADAPT TEP breaks the boundaries of soft tissue repair and enables a Soft Tissue Extracellular Matrix (STEM) to partner with the human body’s natural healing processes to recreate a durable, functional and site specific tissue repair. Through controlled remodelling, the STEM supports the surrounding tissue until the remodelling process is complete and the graft is incorporated by the patient’s own tissue.
bioMD Limited ABN 35 088 221 078 PO Box 7209 Cloisters Square WA 6850 • Tel +61 8 9262 6777 • Fax +61 8 9322 3433 E-mail: [email protected] • Web Site: www.biomd.com.au
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About Cardiovascular Deformities
Specifically, the cardiovascular deformities being repaired are atrial septal defects (ASD), ventricular septal defects (VSD), right ventricular outflow tract reconstructions, and left ventricular and aortic aneurisms.
ASD is a form of congenital heart defect that enables blood flow between the left and right atria. Without this septum, or if there is a defect in this septum, it is possible for blood to travel from the left side of the heart to the right side of the heart, or vice versa.
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The right side of the heart contains venous blood with a low oxygen content, and the left side of the heart contains arterial blood with a high oxygen content. This prevents the atria from regular communication with each other, and thus oxygen rich blood and oxygen deficient blood do not mix together properly.
A ventricular septal defect (VSD) is a defect in the ventricular septum, the wall dividing the left and right ventricles of the heart. VSDs are the most common congenital cardiac anomalies. They are found in 3060% of all newborns with a congenital heart defect.
An aortic aneurysm is a general term for any swelling of the aorta, usually representing an underlying weakness in the wall of the aorta at that location. While the stretched vessel may occasionally cause discomfort, a greater concern is the risk of rupture, which causes severe pain, massive internal hemorrhage and, without prompt treatment, results in a quick death.
A ventricular aneurysm may develop in the wall of the left ventrical after myocardial infarction. A segment of myocardium becomes replaced by scar tissue, which expands to form an aneurysmal sac. Heart failure may result or thrombosis within the aneurysm may act as a source of embolism.
For more information:
Michael Bennett Managing Director +61 8 92626777 or 0419 944567
Robert Towner Executive Director +61 8 92626777 or 0414 594868
About bioMD Limited
bioMD Limited is a biotechnology company based in Perth, Australia and listed on the Australian Securities Exchange (ASX: BOD). bioMD’s focus is to develop new and innovative medical devices either by acquiring technologies, collaborating with research institutions, or investing in private medical companies that have a relatively mature technology or device such as bioMD’s subsidiary company Celxcel.
bioMD Limited ABN 35 088 221 078 PO Box 7209 Cloisters Square WA 6850 • Tel +61 8 9262 6777 • Fax +61 8 9322 3433 E-mail: [email protected] • Web Site: www.biomd.com.au